MAUDE Adverse Event Report: MEDLINE INDUSTRIES HUDSON RCI; ISO-SHIELD CIRCUIT,INFNT,HTD DL,DRAIN

Catalog Number	HUD88015KIT
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Temperature Problem (3022)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated the following : b4: date of this report.D4 - lot#.D4- expiration date.H4- device manufacturer date.E2- health professional.E3- occupation.E4 - changed to yes.H6- medical device problem code a.
Additional Manufacturer Narrative
It was reported that breathing circuits were becoming hot, melting, and requiring circuit to be changed.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
It was reported that breathing circuit were becoming hot, melting, and requiring circuit to be changed.

• Brand Name: HUDSON RCI
• Common Device Name: ISO-SHIELD CIRCUIT,INFNT,HTD DL,DRAIN
• Manufacturer (Section D): MEDLINE INDUSTRIES; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25221347
• Report Number: 1417592-2026-01362
• Device Sequence Number: 21350540
• Product Code: OGG
• UDI-Device Identifier: 10197344010479
• UDI-Public: 10197344010479
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HUD88015KIT
• Device Lot Number: 25DOA334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown